Under the agreement reached between the Council of the European Union and the European Parliament, the revised EU pharmaceutical legislation will shorten standard regulatory data protection while allowing companies to earn back extra years through earlier market launches, clinically relevant innovation and stronger commitments on supply continuity. This shifts leverage towards authorities that can now link valuable protection periods more tightly to timely and equitable access, rather than grant them as a fixed entitlement.
The deal also reinforces security‑of‑supply duties, requiring earlier shortage notifications, risk plans and more systematic information sharing with regulators. National authorities and the European Medicines Agency will have clearer tools to coordinate responses to shortages and demand corrective action, increasing pressure on firms whose products are strategically important but vulnerable to disruption.
The package updates rules for antimicrobial resistance, orphan drugs and paediatric medicines, and introduces a more integrated framework for environmental risk and pharmaceutical pollution. It confirms a more prominent role for the European Commission in steering implementation and in monitoring how member states apply the new rules, including on issues such as shortage management and switches from prescription‑only to non‑prescription status.
Implementation will follow formal adoption by both institutions and application deadlines set out in the legislation, giving companies a limited transition window to adapt development pipelines and launch sequencing. In practice, the deal hardens expectations that future investment decisions will favour products that can demonstrate clear added value, robust supply arrangements and early availability across a critical mass of EU markets.
Source: Council of the European Union
Link: ‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector
Date: 11 December 2025
